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Originally published as JCO Early Release 10.1200/JCO.2006.07.0482 on July 2 2007

Journal of Clinical Oncology, Vol 25, No 23 (August 10), 2007: pp. 3495-3502
© 2007 American Society of Clinical Oncology.

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Two Cycles of Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine Plus Extended-Field Radiotherapy Is Superior to Radiotherapy Alone in Early Favorable Hodgkin's Lymphoma: Final Results of the GHSG HD7 Trial

Andreas Engert, Jeremy Franklin, Hans Theodor Eich, Corinne Brillant, Susanne Sehlen, Claudio Cartoni, Richard Herrmann, Michael Pfreundschuh, Markus Sieber, Hans Tesch, Astrid Franke, Peter Koch, Maike de Wit, Ursula Paulus, Dirk Hasenclever, Markus Loeffler, Rolf-Peter Müller, Hans Konrad Müller-Hermelink, Eckhart Dühmke, Volker Diehl

From the First Department of Internal Medicine, Coordination Center for Clinical Trials, and Department of Radiotherapy, University Hospital of Cologne, Cologne; Department of Radiation Oncology, Ludwig-Maximillans Universität München, München; First Department of Internal Medicine, University Hospital of Hamburg; Department of Internal Medicine II, University Hospital Eppendorf, Homburg; Department of Internal Medicine, Kreiskrankenhaus, Gummersbach; Practice for Hematology and Oncology, Diakonie-Hospital, Frankfurt; Department of Hematology, Otto v. Guericke University, Magdeburg; Department of Oncology, University Hospital of Münster, Münster; Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig; Institute of Pathology, University of Würzburg, Würzburg, Germany; Sezione EMATOLOGIA, Università degli studi "La Sapienza," Roma, Italy; and the Swiss Group for Clinical Cancer Research, Bern, Switzerland

Address reprint requests to Andreas Engert, MD, University Hospital of Cologne, Dept I of Internal Medicine, 50924 Cologne, Germany; e-mail: a.engert{at}uni-koeln.de

Purpose: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL).

Patients and Methods: Between 1993 and 1998, 650 patients with newly diagnosed, histology-proven HL in clinical stages IA to IIB without risk factors were enrolled onto this multicenter study and randomly assigned to receive 30 Gy EF-RT plus 10 Gy to the involved field (arm A) or two cycles of ABVD followed by the same radiotherapy (arm B).

Results: At a median observation time of 87 months, there was no difference between treatment arms in terms of complete response rate (arm A, 95%; arm B, 94%) and overall survival (at 7 years: arm A, 92%; arm B, 94%; P = .43). However, freedom from treatment failure was significantly different, with 7-year rates of 67% in arm A (95% CI, 61% to 73%) and 88% in arm B (95% CI, 84% to 92%; P ≤ .0001). This was due mainly to significantly more relapses after EF-RT only (arm A, 22%; arm B, 3%). No patient treated with CMT experienced relapse before year 3. Relapses were treated mainly with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, or with the combination cyclophosphamide, vincristine, procarbazine, and prednisone/ABVD; treatment of relapse was significantly more successful in arm A than in arm B (P = .017). In total, there were 39 second malignancies, with 21 in arm A and 18 in arm B, respectively. The incidence was approximately 0.8% per year during years 2 to 9 and was highest in older patients (P < .0001) and those with "B" symptoms (P = .012).

Conclusion: CMT consisting of two cycles of ABVD plus EF-RT is more effective than EF-RT alone.

Supported by the Deutsche Krebshilfe and the Swiss Group for Clinical Cancer Research.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

published online ahead of print at www.jco.org on July 2, 2007.




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